Bronchoscopic Laser Ablation of Peripheral Lung Tumors

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Brief Title

Bronchoscopic Laser Ablation of Peripheral Lung Tumors

Official Title

Bronchoscopic Laser Ablation of Solid Peripheral Lung Tumors Followed by Surgical Resection (BLAST-SR Trial)

Brief Summary

      As our population ages and we diagnose early lung cancer in patients who cannot undergo
      surgery due to multiple medical conditions, there is growing interest in minimally invasive
      modalities to treat these tumors. In this study we are assessing the ability of bronchoscopic
      laser ablation to kill the cancer cells in these tumors. Patients will undergo bronchoscopy
      (a tube-like instrument inserted through the mouth to view the inside of the trachea, air
      passages, and lungs). A thin catheter will be passed through the wind-pipes and into the lung
      tumor with computed tomography guidance. A laser probe is then passed through this catheter
      and it is used to destroy the tumor with heat. Patients will then undergo lung surgery with
      resection of the tumor, and the resected specimen will be reviewed to describe the amount of
      tumor-kill produced by the laser.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To assess the pathologic changes that result from bronchoscopic laser ablation of
      peripheral lung tumors focusing on the proportion of complete tumor ablation.

      SECONDARY OBJECTIVES:

      I. To assess the safety of this technique by describing both procedure-related complications
      such as bleeding or pneumothorax and post-procedure adverse effects such as fever or
      pneumonitis.

      II. To assess the pathologic changes observed in the lung tissue surrounding the treated lung
      tumor.

      III. To assess radiographic changes observed by cone-beam computed tomography (CT)
      immediately after the application of bronchoscopic laser ablation.

      OUTLINE:

      Patients undergo bronchoscopic laser ablation following standard bronchoscopy and
      endobronchial ultrasound. Patients also undergo CBCT before and after laser ablation. 48-72
      hours after the procedure, patients undergo standard surgical resection of the lung tumor.
    


Study Type

Interventional


Primary Outcome

Pathologic changes from bronchoscopic laser ablation of peripheral lung tumors

Secondary Outcome

 Incidence of adverse events

Condition

Lung Carcinoid Tumor

Intervention

Cone-Beam Computed Tomography

Study Arms / Comparison Groups

 Diagnostic (bronchoscopic laser ablation, CBCT)
Description:  Patients undergo bronchoscopic laser ablation following standard bronchoscopy and endobronchial ultrasound. Patients also undergo CBCT before and after laser ablation. 48-72 hours after the procedure, patients undergo standard surgical resection of the lung tumor.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

15

Start Date

September 18, 2018

Completion Date

October 31, 2021

Primary Completion Date

October 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Written informed consent

          -  Performance status 0-2 (Eastern Cooperative Oncology Group classification)

          -  Subject is considered a candidate for bronchoscopy

          -  Subject is considered a candidate for surgery (other lobar or sub-lobar resection)
             based on radiographic staging and functional evaluation

          -  Lung lesion that is either biopsy-proven cancer or is suspicious for cancer

          -  Both non-small cell lung cancer (including carcinoid tumors) and metastatic disease

          -  The lesions should be: =< 3 cm, located in the outer 2/3 of the lung, and leave >= 1
             cm of tumor-free lung parenchyma between target tumor and pleura or fissure

        Exclusion Criteria:

          -  Tumors greater than 3 cm, located in the inner 1/3 of the lung, invading a major
             vessel, or located < 1 cm from the pleural or fissure

          -  Tumors qualified as non-resectable

          -  Tumors that cannot be reached bronchoscopically

          -  Patients declared non-surgical candidates

          -  Patients who are not candidates for bronchoscopy

          -  Patients with lung cancer who are found to have N2-3 disease

          -  Patient with lung metastases who are found to have any malignant mediastinal lymph
             node

          -  Patients in which the target lesion is confirmed as benign or small cell lung cancer

          -  Patients without a prior diagnosis of the target lesion whose diagnosis cannot be made
             during bronchoscopy

          -  Patients who have received chemotherapy within 60 days prior to bronchoscopic laser
             ablation

          -  Patients who were previously treated for the target lesion

          -  Pregnant patients
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Roberto F Casal, 713-792-6238, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03707925

Organization ID

2018-0474

Secondary IDs

NCI-2018-02133

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Roberto F Casal, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

July 2019